An Exercise and Lifestyle Programme for Adults With Vascular Ehlers-Danlos Syndrome: A Feasibility Study

Официальное название

Co-Producing and Piloting an Exercise-Based Lifestyle Intervention for Individuals With Vascular Ehlers-Danlos Syndrome (vEDS): A Mixed-Methods Feasibility Study

Обзор

Vascular Ehlers-Danlos syndrome (vEDS) is a rare, life-threatening connective tissue disorder. People with vEDS have often been advised to limit physical activity, yet the safety and feasibility of structured exercise in this group is poorly understood. This study works with people with vEDS, their families and clinicians to co-design a safe, tailored physical activity programme, then tests it in a 12-week randomised feasibility study comparing the programme with usual care. The aim is to find out whether the intervention and the trial procedures are safe, acceptable and practical, in order to inform a future full-scale trial. Outcomes focus on recruitment, retention, adherence, acceptability and safety, alongside exploratory measures of physical function, quality of life and microvascular health.

Подробное описание

This is a mixed-methods feasibility study delivered across four phases. Phase 1 uses qualitative interviews with people with vEDS, family members and clinicians to understand experiences of physical activity and decision-making under uncertain clinical guidance. Phase 2 uses co-production focus groups to design the exercise-based lifestyle intervention. Phase 3 is a 12-week randomised feasibility trial in which adults with vEDS are randomised to the co-produced intervention or to usual care, assessing feasibility outcomes (recruitment, retention, adherence, data completeness, acceptability and safety) and exploratory clinical measures. Phase 4 uses post-intervention interviews to explore participant experiences and refine the intervention. The registered trial corresponds to the Phase 3 randomised feasibility component; the qualitative phases provide the development and evaluation context.

Вмешательства

• Поведенческое Co-designed exercise-based lifestyle intervention
  A 12-week individually tailored exercise-based lifestyle programme, co-produced with people with vEDS, delivered remotely with supervision and weekly monitoring. Comprises low-intensity, low-impact aerobic and functional activity progressed to individual capacity, with behavioural support to encourage sustained physical activity.

Первичные конечные точки

• Recruitment rate [Срок оценки: From study start through completion of recruitment, up to 12 months]
• Retention rate [Срок оценки: 12 weeks]
• Adherence [Срок оценки: Over the 12-week intervention period]
• Data completeness [Срок оценки: Baseline and 12 weeks]
• Acceptability [Срок оценки: 12 weeks]
• Adverse events and serious adverse events [Срок оценки: Throughout the 12-week intervention period]

Вторичные конечные точки (11)

• Fatigue [Срок оценки: Baseline and 12 weeks]
• Anxiety and depression [Срок оценки: Baseline and 12 weeks]
• Health-related quality of life [Срок оценки: Baseline and 12 weeks]
• Physical activity [Срок оценки: Baseline and 12 weeks]
• Lower-limb strength and endurance [Срок оценки: Baseline and 12 weeks]
• Sub-maximal aerobic capacity [Срок оценки: Baseline and 12 weeks]
• Muscle strength [Срок оценки: Baseline and 12 weeks]
• Functional mobility [Срок оценки: Baseline and 12 weeks]
• Orthostatic heart rate response [Срок оценки: Baseline and 12 weeks]
• Orthostatic blood pressure response [Срок оценки: Baseline and 12 weeks]
• Microvascular function [Срок оценки: Baseline and 12 weeks]

Критерии участия

Критерии включения

• Adults aged 18 years or older
• Confirmed diagnosis of vascular Ehlers-Danlos syndrome (vEDS)
• Living in the UK
• Able to provide informed consent
• Medically stable, defined as: no arterial dissection, rupture, or other major vEDS-related vascular event within the preceding 6 months; no recent hospitalisation for vEDS complications; and blood pressure considered controlled by their treating clinician
• Medical clearance from their treating clinician
• Not pregnant at the time of enrolment

Критерии исключения

• Major vEDS-related vascular event (arterial dissection or rupture) within the previous 6 months
• Recent hospitalisation for vEDS complications
• Blood pressure not controlled by treating clinician
• Pregnancy at enrolment (participants who become pregnant during the intervention are withdrawn from the exercise component but may continue follow-up data collection if they wish)
• Unable to provide informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Великобритания · 1 центр

• Sheffield Hallam University — Sheffield

Идентификаторы

NCT: NCT07697573 · IRAS361077 · 26/NE/0025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗